6-ethyl-2-toluidine

Basic toxicokinetics

Administrative data

Endpoint:

basic toxicokinetics in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: sufficient information to be taken into account

Data source

Reference

Reference Type:

publication

Title:

Radiotracer appoaches ito rodent dermal studies.

Author:

Marco, G., J.; Simoneaux, B., J.; Williams, S., C; Cassidy, J., E.; Bissig, R.; Muecke, W.

Year:

1985

Bibliographic source:

Am. Chem. Soc. Symp Ser. 273, 43-61

Materials and methods

Objective of study:

toxicokinetics

Principles of method if other than guideline:

Method: other: dermal absorption study

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

6-ethyl-2-toluidine

EC Number:

246-309-6

EC Name:

6-ethyl-2-toluidine

Cas Number:

24549-06-2

Molecular formula:

C9H13N1

IUPAC Name:

2-ethyl-6-methylaniline

Details on test material:

IUCLID4 Test substance: other TS: 2-methyl-6-ethylanilin hydrochloride, no data on purity

Radiolabelling:

yes

Remarks:

14C-phenly-2-ethyl-6-methyl aniline hydrochloride

Test animals

Species:

rat

Sex:

male

Administration / exposure

Route of administration:

dermal

Duration and frequency of treatment / exposure:

48 hour(s)

Doses / concentrations

Remarks:

Doses / Concentrations:
Males: 0.1 mg/kg bw

No. of animals per sex per dose / concentration:

3 per dose and phase

Control animals:

not specified

Results and discussion

Preliminary studies:

no data

Toxicokinetic / pharmacokinetic studies

Details on excretion:

The main (60 % of dose) urinary component was identified as the sulfate ester conjugate of 2-ethyl-4-hydroxy-6-methylaniline

Toxicokinetic parameters

Toxicokinetic parameters 1

Toxicokinetic parameters:

half-life 2nd:

Toxicokinetic parameters 2

Toxicokinetic parameters:

half-life 1st:

Toxicokinetic parameters 3

Toxicokinetic parameters:

half-life 3rd:

Metabolite characterisation studies

Details on metabolites:

In an occlusive dermal absorption study with rats, the metabolic fate and urine metabolites were evaluated. The majority of the test substance was found in the urine (78.4 %), a minority in the feces (2.3 %) and even less in the exelerated CO2 (1.3%). The main (60% of dose) urine metabolic metabolite was the sulfate ester conjugate of 2 -ethyl-4hydroxy-6 -methylaniline (Marco1985).

Any other information on results incl. tables

RS-Freetext:
Study of the occlusive dermal absorption of
2-ethyl-6-methyl aniline hydrochloride in rats (dose: 0.1
mg/kg bw 14C-phenyl-2-ethyl-6-methyl aniline hydrochloride
= MEA):  
  
after 48 h amount in % of the radioactive dose.
urine    78.4 % 
feces     2.3 %
CO2       1.3 %
skin      2.0 %
foil      4.2 %
adhesive  6.0 %
carcass   3.1 % 
cage wash 0.7 %

TOTAL: 98 %

The main (60 % of dose) urinary component was identified as the sulfate  ester conjugate of 2-ethyl-4-hydroxy-6-methylaniline

Applicant's summary and conclusion

Executive summary:

In an occlusive dermal absorption study with rats, the metabolic fate and urine metabolites were evaluated. The majority of the test substance was found in the urine (78.4 %), a minority in the feces (2.3 %) and even less in the exelerated CO2 (1.3%). The main (60% of dose) urine metabolic metabolite was the sulfate ester conjugate of 2 -ethyl-4hydroxy-6 -methylaniline (Marco1985).